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140.634.81
Non-Inferiority and Equivalence Clinical Trials

Location
Internet
Term
3rd Term
Department
Biostatistics
Credit(s)
2
Academic Year
2012 - 2013
Instruction Method
TBD
Auditors Allowed
Yes, with instructor consent
Available to Undergraduate
No
Grading Restriction
Pass/Fail
Contact Name
Simon Day
Contact Email
Frequency Schedule
Every Year
Prerequisite

Students must take or have taken Introduction to Online Learning; good understanding of clinical trials (examples: Principles of Epidemiology [340.601] or equivalent, Statistical Reasoning I-II [140.611-612] or equivalent); Biostatistics in Medical Product Regulation (140.633) or equivalent

Description
Presents the important differences between superiority trials and those intended to show either equivalent effect, or to show that one therapy is no worse than another (but might be better). Explores the problems of setting equivalence margins, preservation of some proportion of active control effect, and emphasizes the use of confidence intervals to interpret the results of studies. Discusses special issues of quality of the trial conduct, assay sensitivity, historical evidence of treatment effects and assumptions of constancy of treatment effects over time. Compares sample size requirements between superiority trials, equivalence trials and non-inferiority trials. Discusses the use of different analysis populations (ITT and per-protocol) and issues of changing conclusions between non-inferiority and superiority. Discusses the regulatory aspects of trial design and interpretation, and reviews existing regulatory guidance.
Learning Objectives
This course will prepare you to be able to do the following:
  1. Define “superiority,” “equivalence” and “non-inferiority” clinical trials.
  2. Assess the adequacy of published examples of equivalence and non-inferiority trials
  3. Design equivalence and non-inferiority trials, knowing what special features are required
  4. Present results from trials so that equivalence or non-inferiority can be adequately interpreted
Jointly Offered With
Special Comments

Course is pass/fail only, no letter grades. Students must have access to appropriate web tools to take on-line lectures, quizzes (which constitute 15% of the total grade) and exam, and to take part in LiveTalks.